UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015905 |
|---|---|
| Receipt number | R000018482 |
| Scientific Title | Treatment of the skin manifestations of Darier's disease by the topical application of COX-2 inhibitors |
| Date of disclosure of the study information | 2014/12/25 |
| Last modified on | 2018/06/12 11:10:11 |
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Basic information
Public title
Treatment of the skin manifestations of Darier's disease by the topical application of COX-2 inhibitors
Acronym
Treatment of Darier's disease by the topical application of COX-2 inhibitors
Scientific Title
Treatment of the skin manifestations of Darier's disease by the topical application of COX-2 inhibitors
Scientific Title:Acronym
Treatment of Darier's disease by the topical application of COX-2 inhibitors
Region
| Japan |
Condition
Condition
Darier's disease
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Therapy and safety evaluation of the topical COX-2 inhibitor treatment on the skin manifestations of Darier's disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of skin manifestations which are evaluated by Psoriasis Area and Severity Index score after 3-month treatment
Key secondary outcomes
Safety evaluation: Common terminology criteria for adverse events v4.0 grade 3-5
Therapy evaluation: Pathological findings and level of expression of ATP2A2 after 3-month treatment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Topical application of 1% diclofenac sodium gel
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients of Darier's disease diagnosed by clinical manifestation and pathological finding
Key exclusion criteria
1) Patients without disease notification
2) Patients who do not join "Development of the genetic diagnosis system of congenital and Inherited skin disorders (UMIN000009851)"
3) Aspirin-induced asthma patients
4) Patients with diclofenac sodium allergy
5) Pregnant women
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akiharu Kubo |
Organization
Keio University School of Medicine
Division name
Department of Dermatology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
akiharu@keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiharu Kubo |
Organization
Keio University School of Medicine
Division name
Department of Dermatology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
akiharu@keio.jp
Sponsor or person
Institute
Department of Dermatology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Dermatology, Keio University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
慶應義塾大学医学部（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2014 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 10 | Day |
Last modified on
| 2018 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018482
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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